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Targeting subjects with high numbers of particles that carry "bad cholesterol" in the blood to best prevent type 2 diabetes

Condition category

Nutritional, Metabolic, Endocrine

Date applied

26/07/2017

Date assigned

28/07/2017

Last edited

25/09/2017

Prospective/Retrospective

Retrospectively registered

Overall trial status

Completed

Recruitment status

No longer recruiting

Plain English Summary

Background and study aimsType 2 diabetes is a worldwide health burden leading to other diseases and death. It develops when our body is not responding well to the important actions of insulin. Insulin is a hormone that helps our body to function well and to make use of the food that we eat. If the body is not responding well to insulin, the sugar will accumulate in the blood leading to the diagnosis of diabetes. Having excess weight increases the chance of becoming diabetic. Type 2 diabetes can be prevented by weight-loss. However, there is a need to identify the overweight or obese patients who will most likely become diabetic in order to best prevent this disease. Having high numbers of particles that carry cholesterol in the blood (or apoB) could increase the chance for developing diabetes. This is because high blood apoB decreases the function of our tissues, like fat and muscle, which decreases their response to insulin. Accordingly, we believe that targeting subjects with high blood apoB with weight-loss programs would lead to maximal prevention of type 2 diabetes among a population of overweight and obese subjects. The aim of this study is to identify those who are high risks of developing type 2 diabetes based on certain markers in their blood samples.

Who can participate?Adults aged 45 to 74 years old who are overweight

What does the study involve?Participants are asked to follow a healthy weight-loss program for six month using a low-calorie diet, which is based on the Canadian Food Guide. To encourage this, participants meet with dieticians for one hour each month. Participants are encouraged to maintain their normal activity level during the six months. Participants are asked to keep a three day food intake record at the beginning and end of the study. Participants are followed up with blood tests to analyse their cholesterol levels in their blood.

What are the possible benefits and risks of participating?Participants may benefit from being enrolled in a weight-loss program under close nutritional and medical supervision. They also may benefit from having access to in-depth medical examination using combinations of tests that are only accessible through medical research. There are no direct risks with participating.

Where is the study run from? Montreal Clinical Research Institute (Institut de Recherches cliniques de Montréal (IRCM))

When is the study starting and how long is it expected to run for? October 2007 to August 2014

Who is funding the study?Canadian Institutes of Health Research (Canada)

Study design

Primary study design

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Prevention

Patient information sheet

No participant information sheet available’

Condition

ApoB-lipoproteins and risk for type 2 diabetes

Intervention

Participants are asked to follow a hypocaloric diet for six months. The diet is administered during individual sessions by two registered dietitians. Daily energy needs are calculated as basal metabolic rate, measured by an indirect calorimetry, multiplied by a sedentary physical activity factor of 1.4, from which 500 kcal were subtracted.

Participants are counseled to follow a balanced diet based on the Canadian Food Guide and Health Canada (45-65% carbohydrate, 20-35% fat and 15-35% protein). To encourage compliance, subjects met monthly with the dietitians for one hour, during which body weight is also recorded.

Participants are encouraged to maintain their habitual (i.e. sedentary) activity level during the six month intervention. Prior to the baseline and post-intervention metabolic testing, subjects undergo a weight stability period of four weeks (± 2 kg), with their weight being verified weekly at the the study centre.

Secondary outcome measures

1. Blood pressure is measured using an automated machine at baseline and seven months 2. Waist and hip circumferences is measured using a measure tape at baseline and seven months 3. Metabolic rate and macronutrient oxidation rates are measured using indirect calimetry at baseline and seven months 4. Dietary intake is measured using 3-day food intake records at baseline and six months (directly at the end of the hypocaolic diet) 5. Plasma C-peptide is measured using a commercial RIA kit at baseline and seven months 6. Fatty acids are measured using a commercial kit at baseline and seven months 7. ApoB48 is measured using a commercial hsELISA kit at baseline and seven months 8. apoA-1 is measured using an automated analyzer at baseline and seven months 9. PCSK9 is measured using a commercial hsELISA kit at baseline and seven months

Funder name

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Canada

Results and Publications

Publication and dissemination plan

Baseline data are already published in peer reviewed journals and presented at national and international conferences.

IPD sharing statement:The datasets generated during and/or analysed during the current study is not expected to be made available as we did not seek consent from participants to share their data publically. Additional sample and data analysis can be conducted in collaboration with Dr May Faraj